Clinical Trial to Evaluate the Safety and Effectiveness of the IBV® Valve System for the Treatment of Severe Emphysema - Full Text View

Sponsor:	Spiration, Inc.
Information provided by:	Spiration, Inc.
ClinicalTrials.gov Identifier:	NCT00475007

Purpose

This trial is for men and women between the ages of 40 and 74 who have a confirmed diagnosis of emphysema. The objective of the trial is to determine the safety and effectiveness of the IBV Valve at redirecting airflow from diseased portions of the lung to healthier areas to achieve improvement in disease-related health status.

Condition	Intervention	Phase
Emphysema COPD	Device: IBV® Valve System	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Prospective, Randomized, Controlled Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of the IBV® Valve System for the Treatment of Severe Emphysema

Resource links provided by NLM:

MedlinePlus related topics: Emphysema

U.S. FDA Resources

Further study details as provided by Spiration, Inc.:

Primary Outcome Measures:

Difference between responder rates of the treatment & control groups, responders defined as subjects with clinically meaningful improvements in disease-related health status (SGRQ) & regional lung volume changes as measured by quantitative CT scan. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The difference between average 6 minute walk test results for treatment & control groups. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	September 2007
Estimated Study Completion Date:	October 2015
Estimated Primary Completion Date:	October 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 The experimental group will have an investigational medical device implanted in their lungs with an instrument known as a bronchoscope. This procedure is done without an incision	Device: IBV® Valve System The IBV Valve is a small, umbrella shaped device designed to redirect airflow to healthier areas of the lungs. It is implanted without incisions using a bronchoscope.
Sham Comparator: 2 The sham comparator group will be tested, treated and followed in an identical manner as the experimental group, except that no valves will be placed during the diagnostic bronchoscopy, the sham procedure.	Device: IBV® Valve System The IBV Valve is a small, umbrella shaped device designed to redirect airflow to healthier areas of the lungs. It is implanted without incisions using a bronchoscope.

Detailed Description:

The IBV Valve Trial is a multi-center clinical trial evaluating the IBV Valve System, a non-surgical treatment for patients with emphysema. The IBV Valve System does not require traditional surgery or surgical incisions. The valves are placed during a bronchoscopic procedure. The IBV Valve System is designed to redirect airflow from diseased portions of the lung to healthier areas to achieve improvement in disease-related health status. Although the valves are intended to be permanent, they are designed to be removed if necessary.

The IBV Valve Trial is a randomized, blinded trial. This means that participants are divided into two groups but do not know to which group they have been assigned.

The IBV Valve Treatment Group receives valves, and the Control Group does not. A random selection process decides the group assignments (participants will not be able to choose their group). In the trial, everyone will have a 50 percent chance (similar to a coin toss) to be assigned to one group or the other.

All Participants in this Clinical Trial will:

Receive a diagnostic bronchoscopy that will allow an expert in lung health to evaluate their lungs.

Be under the care of a highly qualified lung doctor for the entire time they are in the trial, regardless of whether they are in the Treatment Group or the Control Group.

Receive regular periodic check-ups and health assessments throughout the 6 month trial period.

The procedure, all testing, and doctor visits are provided at no cost to participants of both the IBV Valve Treatment Group and the Control Group.

At the completion of their 6-month visit, participants will be told if they were assigned to the Treatment Group or the Control Group. If participants were assigned to the group that did not receive valves (the Control Group), they will be given the option to be re-evaluated by the clinical trial doctor, to determine if they can have valve treatment.

Eligibility

Ages Eligible for Study:	40 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Candidates have mostly upper lobe, severe emphysema.
Must be able to participate in standard exercise testing.
Willing to abstain from cigarette smoking for 4 months prior and during the entire trial.
Willing to participate in a randomized, blinded study and complete the required follow-up visits during the study period.
Willing to participate in multiple visits to a medical center for health assessment tests.
Willing to have a minimum of one overnight stay in the hospital.

Exclusion Criteria:

Evidence of another co-existing major medical disease.
Unable to tolerate, flexible bronchoscopy procedures.
Active asthma, chronic bronchitis.
Diffuse emphysema pattern, alpha 1-antitrypsin deficiency.
Has had prior lung volume reduction surgery.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475007

Show 34 Study Locations

Sponsors and Collaborators

Spiration, Inc.

More Information

No publications provided

Responsible Party:	Steven C. Springmeyer, MD; Vice President and Medical Director, Spiration, Inc
ClinicalTrials.gov Identifier:	NCT00475007 History of Changes
Other Study ID Numbers:	CPR-01377
Study First Received:	May 16, 2007
Last Updated:	June 14, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Spiration, Inc.:

Emphysema
IBV® Valve
COPD
Shortness of Breath
Spiration

Additional relevant MeSH terms:

Emphysema
Pulmonary Emphysema
Pulmonary Disease, Chronic Obstructive
Pathologic Processes

Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive

ClinicalTrials.gov processed this record on February 09, 2012